2008 Weight Loss, Protein and Bone Density study

Phase 4

Completed

• Conditions: Obesity; Diet and Nutrition - Obesity

• Registration Number: ACTRN12608000229370
• Lead Sponsor: CSIRO Human Nutrition

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Female, post menopausal
• Aged between 40-70 years
• Body Mass Index (BMI) greater than 27, but a maximum weight of 140kg
• Participants must understand the procedures involved and agree to participate in the study by giving full informed, written consent

Exclusion Criteria

• Body mass index (BMI) less than 27
• Taking antiresorptive agents –including Hormone Replacement Therapy
• Vitamin D and/or parathyroid hormone (PTH) and/or serum calcium levels outside the normal range when tested at baseline. If vitamin D is less than 60 and PTH is normal participants will continue in the study but if PTH is also elevated then the participant will be withdrawn and referred to their GP for active treatment.
• Taking agents affecting calcium and bone metabolism such as calcium supplements, steroids or diuretics.
• Bone density in the osteoporotic density range (total hip 2 SD below normal) or a history of low trauma peripheral or spinal fracture (with density <1 SD below normal) as assessed at the baseline examination.
• Have a malignancy, or a history of metabolic disease such as liver, renal, unstable cardiovascular, respiratory or gastrointestinal disease.
• Have high uncontrolled hypertension (resting recumbent Blood Pressure >160/100 mmHg). Once controlled on medication the participant can enter the study
• History of heavy alcohol consumption (> 5 standard drinks/day)
• Unwilling to be randomized to either trial group
• Extended absences due to travel or other commitments
• Unable to comprehend or cope with study requirements
• At the commencement of the study bone density at the hip, spine and forearm will be measured. Those women in the osteoporotic density range (very low bone density ) at the first examination will not be eligible to participate but will be referred back to their general practitioner for specific treatment. Those with osteopenia (moderately low bone density) and no fractures will be able to continue in the study if they wish.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
weight, DEXA (dual energy x-ray absoptiometry), blood tests including vitamin D[baseline, 3 months, 6 months, 12 months and 24 months]

Secondary Outcome Measures

Name	Time	Method
24hour urinary urea, creatinine, calcium, sodium, phosphate.<br>Fasting urine pH, calcium, creatinine, sodium, phosphate.[baseline, 3 months, 6 months, 12 months and 24 months]